Report Shows Theranos Blood Tests Fail Even the Company's Standards

Theranos founder and CEO Elizabeth Holmes at the Fortune Global Forum, November 2015. ( Stuart Isett/Fortune Global Forum)

This has been another bad week for the Palo Alto-based consumer blood testing company, Theranos. Since last year, the start-up has been dogged by regulatory troubles.

A newly released federal inspection report, by the Centers for Medicare and Medicaid Services (CMS), has found that the company's testing devices often fail the firm’s own accuracy requirements.

The 121 page redacted report about Theranos’s Newark laboratory, revealed that the company’s much touted finger-prick blood tests failed quality control checks nearly 30 percent of the time.

John Carreyrou is an investigative reporter for The Wall Street Journal who has been covering Theranos and first reported the story today.  He told KQED’s Danielle Venton that the company's pattern has been to criticize any information made public by others.

“This data is important because it comes directly from the company. The company can't say, 'well this person or that person has an agenda and they are out to get us'. This is their own data," says Carreyrou.

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“This is [government inspectors] going in and looking at data and records from Theranos itself and then reporting that the records show an incredibly high rate of failure during quality checks, incredibly wide variations," explains Carreyrou.

In reviewing the report, Carreyrou described a hormone test that failed 87 percent of quality control tests during one month and a test to help detect prostate cancer failed more than 20 percent of the time.

The current report follows an independent study, released earlier in the week, also showing inconsistent lab results.

Theranos, which has claimed its technology would revolutionize the blood testing industry, is now facing potential penalties. Carreyrou said that his understanding is that federal regulators plan to impose sanctions that could range from fines to a retraction of the company’s approval to test human samples.

When reached for comment about the government report, Theranos spokesperson, Brooke Buchanan, said, "Quality and patient safety is our top priority. Theranos submitted a Plan of Correction to CMS and related evidence that addressed how the company has actively ensured that our lab operates at the highest standard. We’ve made mistakes in the past in the Newark, CA lab, but when the company was made aware of the deficiencies we have dedicated every resource to remedy those failures."

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In KQED's own interviews with Theranos and government regulators, we have not been able to clarify how many patients have been affected, or what they may have been told about the blood testing irregularities.

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